A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
NCT03430063 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2022-11-03
Summary
The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in \<50% of tumor cells.
Conditions
- Advanced Non-Small Cell Lung Carcinoma
Interventions
- DRUG
-
SDREGN2810
Standard dose intravenous (IV) infusion
- DRUG
-
SDREGN2810/ipi
Combination therapy dose IV
- DRUG
-
HDREGN2810
High dose IV
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-29
- Primary Completion
- 2021-10-27
- Completion
- 2021-10-27
- FDA Drug
- Yes
Countries
- United States
- Belgium
- France
- Germany
- Poland
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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